Ruxolitinib in Patients With Breast Cancer

NCT01562873 | Terminated Phase 2 Results DMC

• 1 other identifier: 12-024
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is thought that this pathway might be important in certain types of breast cancer, and that blocking this pathway might lead to anti-cancer effects. This study is testing the effects of ruxolitinib in patients with breast cancer.

Conditions

Breast Cancer

Keywords

pSTAT3+

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

  Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity up to 12 cycles. Treatment duration was a median of 2 cycles range (1-5).

Secondary Outcomes (3)

• Clinical Benefit Rate

  Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity up to 12 cycles. Treatment duration was a median of 2 cycles range (1-5).

• Overall Survival

  In long-term follow-up, patients were followed for survival every 4 months for up to 2 years. Median follow-up in this study cohort was 4.5 months (range 0.6-21.9).

• Progression-Free Survival

  Disease was evaluated radiologically every 8 weeks on treatment through 12 cycles and in long-term follow-up every 4 months for up to 2 years. Median follow-up in this study cohort was 4.5 months (range 0.6-21.9).

Study Arms (2)

Ruxolitinib-Cohort A

EXPERIMENTAL

Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of \>/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).

Drug: Ruxolitinib

Ruxolitinib-Cohort B

EXPERIMENTAL

Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of \>/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).

Drug: Ruxolitinib

Interventions

Ruxolitinib DRUG

Also known as: INCB018424, Jakafi

Ruxolitinib-Cohort A; Ruxolitinib-Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed invasive breast cancer
• Must have known ER, PR and HER2 status
• Either, Triple Negative Metastatic Breast Cancer or
• Inflammatory Breast Cancer with any ER, PR HER2 status
• Availability of archival tissue specimen suitable for pStat3 testing
• Life expectancy of greater than 3 months
• Measurable disease by RECIST
• At least one prior chemotherapy regimen for treatment of metastatic breast cancer and/or recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy or
• For patients with inflammatory breast cancer but no distant metastases, progression through standard neoadjuvant chemotherapy is required

You may not qualify if:

• Pregnant or breastfeeding
• Active brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib
• Clinically significant malabsorption syndrome
• Concurrent use of medications/substances that are strong inhibitors of CY3A4
• No uncontrolled intercurrent illness

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Nancy Lin, MD
• Organization: Dana-Farber Cancer Institute

Nancy_Lin@dfci.harvard.edu

617.632.2335

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 26, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)